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Safety and Effectiveness of BENLYSTA (Belimumab) in Systemic Lupus Erythematosus (SLE) Registry

NCT ID: NCT01729455

Last Updated: 2025-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

3138 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-02-21

Study Completion Date

2025-02-28

Brief Summary

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The purpose of this prospective, observational cohort study is to evaluate the incidence of adverse events of special interest (AESI) and effectiveness in participants with active, autoantibody-positive SLE treated with and without BENLYSTA (belimumab). Participants will be enrolled into 1 of 2 cohorts: (1) BENLYSTA cohort: participants receiving or initiating BENLYSTA plus standard of care (SOC) at Baseline; (2) comparison cohort: participants not receiving BENLYSTA but receiving SOC at Baseline. After enrollment, changes in lupus medications, including starting or stopping BENLYSTA, are at the discretion of the physician, and all participants will continue to be followed regardless of changes in their lupus medicines until study completion. All participants will be assessed for AESI including serious infections, opportunistic infections and other infections of interest, malignancies, selected serious psychiatric events and mortality. Data will be collected at enrollment and at 6 month intervals for 5 years. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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BENLYSTA cohort

Participants with active, autoantibody-positive SLE treated with BENLYSTA at Baseline.

BENLYSTA

Intervention Type BIOLOGICAL

As prescribed.

Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

SLE treatment

Intervention Type OTHER

As prescribed.

At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Comparison cohort

Participants with active, autoantibody-positive SLE treated without BENLYSTA at Baseline.

SLE treatment

Intervention Type OTHER

As prescribed.

At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Interventions

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BENLYSTA

As prescribed.

Belimumab is a recombinant, human, IgG1λ monoclonal antibody for the treatment of systemic lupus erythematosus.

Intervention Type BIOLOGICAL

SLE treatment

As prescribed.

At baseline, SLE treatment must include an immunosuppressant. During the registry, SLE treatment may include any of the following (alone or in combination): immunosuppressants, corticosteroids, antimalarials, other biologics, investigational agents for SLE, as clinically indicated.

Intervention Type OTHER

Other Intervention Names

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belimumab

Eligibility Criteria

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Inclusion Criteria

* Males or females age 18 years or older.
* Have a clinical diagnosis of active SLE.
* Current or history of autoantibody-positive SLE.
* Must be treated with SLE therapy including BENLYSTA and/or immunosuppressants (for example, azathioprine, methotrexate, cyclophosphamide, mycophenolate, and biologics).
* Have the ability to understand the requirements of the study, provide written informed consent, including consent for the use and disclosure of research-related health information, and comply with the study data collection procedures.

Exclusion Criteria

* Treatment with an investigational drug within one year of enrollment. Investigational drug applies to any drug not approved for sale in the country it is being used.
* Currently enrolled in a placebo-controlled BENLYSTA (belimumab) clinical trial or a continuation protocol where belimumab is used as an investigational agent.
* Participants who have a history of BENLYSTA exposure, but are not currently receiving BENLYSTA.
* Participants only receiving an anti-malarial for SLE.
* Participants only receiving steroids for SLE.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Birmingham, Alabama, United States

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Glendale, Arizona, United States

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Goodyear, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Prescott, Arizona, United States

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Sun City, Arizona, United States

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Tucson, Arizona, United States

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Tucson, Arizona, United States

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Bakersfield, California, United States

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La Mesa, California, United States

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Lakewood, California, United States

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Loma Linda, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Murrieta, California, United States

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Pomona, California, United States

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Upland, California, United States

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West Hills, California, United States

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Danbury, Connecticut, United States

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New Haven, Connecticut, United States

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Orangeburg, Connecticut, United States

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Brandon, Florida, United States

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Clearwater, Florida, United States

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Fort Lauderdale, Florida, United States

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Jupiter, Florida, United States

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Largo, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Palm Harbor, Florida, United States

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Pembroke Pines, Florida, United States

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Pensacola, Florida, United States

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Plantation, Florida, United States

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Atlanta, Georgia, United States

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Gainesville, Georgia, United States

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Meridian, Idaho, United States

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Chicago, Illinois, United States

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Chicago, Illinois, United States

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Morton Grove, Illinois, United States

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South Bend, Indiana, United States

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Baton Rouge, Louisiana, United States

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Shreveport, Louisiana, United States

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Baltimore, Maryland, United States

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Springfield, Massachusetts, United States

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Ann Arbor, Michigan, United States

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Ann Arbor, Michigan, United States

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Detroit, Michigan, United States

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Eagan, Minnesota, United States

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Edina, Minnesota, United States

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Jackson, Mississippi, United States

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Tupelo, Mississippi, United States

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St Louis, Missouri, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Summit, New Jersey, United States

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Teaneck, New Jersey, United States

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Voorhees Township, New Jersey, United States

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Manhasset, New York, United States

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Mineola, New York, United States

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New York, New York, United States

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Roslyn, New York, United States

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Smithtown, New York, United States

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The Bronx, New York, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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New Bern, North Carolina, United States

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Rocky Mount, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Edmond, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Oklahoma City6, Oklahoma, United States

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Tulsa, Oklahoma, United States

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Duncansville, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Pittsburgh, Pennsylvania, United States

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Charleston, South Carolina, United States

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Charleston, South Carolina, United States

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Hixson, Tennessee, United States

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Nashville, Tennessee, United States

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Allen, Texas, United States

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Arlington, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Nassau Bay, Texas, United States

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Round Rock, Texas, United States

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San Marcos, Texas, United States

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The Woodlands, Texas, United States

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Danville, Virginia, United States

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Norfolk, Virginia, United States

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Roanoke, Virginia, United States

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Seattle, Washington, United States

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Glendale, Wisconsin, United States

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Manitowoc, Wisconsin, United States

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Buenos Aires, , Argentina

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Ciudad autOnoma de Bueno, , Argentina

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Paraná, , Argentina

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Graz, , Austria

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Linz, , Austria

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Vienna, , Austria

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Leuven, , Belgium

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Elmshorn, , Germany

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Halle, , Germany

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Heidelberg, , Germany

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Jena, , Germany

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Kiel, , Germany

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Leipzig, , Germany

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Mainz, , Germany

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Püttlingen, , Germany

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Stuttgart, , Germany

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Ashkelon, , Israel

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Haifa, , Israel

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Haifa, , Israel

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Jerusalem, , Israel

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Nahariya, , Israel

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Petah Tikva, , Israel

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Ramat Gan, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Brescia, , Italy

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Milan, , Italy

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Milan, , Italy

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Milan, , Italy

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Padua, , Italy

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Pisa, , Italy

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Roma, , Italy

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Roma, , Italy

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Siena, , Italy

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Udine, , Italy

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Lisbon, , Portugal

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Bratislava, , Slovakia

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Košice, , Slovakia

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Košice, , Slovakia

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Piešťany, , Slovakia

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Piešťany, , Slovakia

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A Coruña, , Spain

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Alicante, , Spain

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BaracaldoVizcaya, , Spain

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Barcelona, , Spain

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Barcelona, , Spain

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Getafe, , Spain

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Las Palmas, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Madrid, , Spain

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Murcia, , Spain

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Santander, , Spain

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Toledo, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Valladolid, , Spain

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VigoPontevedra, , Spain

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Villajoyosa, , Spain

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Stockholm, , Sweden

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Countries

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United States Argentina Austria Belgium Canada France Germany Israel Italy Portugal Slovakia Spain Sweden

Other Identifiers

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HGS1006-C1124

Identifier Type: OTHER

Identifier Source: secondary_id

116543

Identifier Type: -

Identifier Source: org_study_id

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